Cortisone Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hikma Pharmaceutical (2013-09-04)
Oldest Current Product
1972-06-13
License(s)
ANDA
RxNORM
ORAL TABLET\CORTISONE
FDAOB
INJECTION\INJECTION\CORTISONE ACETATE\rdfq
ORAL\TABLET\CORTISONE ACETATE
SPL Active
ORAL\TABLET\CORTISONE ACETATE
SPL Moiety
ORAL\TABLET\CORTISONE

product(s) by strength(s)

cortisone acetate 25 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001431202ANDAWest-Ward Pharmaceutical Corp1972-06-13CORTISONE ACETATEORALTABLETANDA0807765d59b43c-f10d-463f-92df-6171d02b7a45
2001439700ANDAWest-Ward Pharmaceutical Corp2013-08-22CORTISONE ACETATEORALTABLETANDA08077685cfed58-e5f1-4170-8d83-60e6bebd3610
3591150161ANDAHikma Pharmaceutical2013-08-26CORTISONE ACETATEORALTABLETANDA080776f7548498-142c-4feb-83ed-4c20dcd6108b

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1604290015ANDAGolden State Medical Supply, Inc.1972-06-13CORTISONE ACETATEORALTABLET001431202ANDA080776105133d9-2991-4dd2-8d99-beb81aed8aad

application(s)

#idtitledeprecatedapplicantapproved drug
1ANDA080333CORTISONE ACETATETrueVITARINE PHARMACEUTICALS INCANDA080333_001
2ANDA080341CORTISONE ACETATETrueWHITEWORTH TOWNE PAULSEN INCANDA080341_001
3ANDA080493CORTISONE ACETATETruePUREPAC PHARMACEUTICAL COANDA080493_001
4ANDA080630CORTISONE ACETATETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USAANDA080630_001
5ANDA080694CORTISONE ACETATETrueLANNETT CO INCANDA080694_001
6ANDA080731CORTISONE ACETATETrueINWOOD LABORATORIES INC SUB FOREST LABORATORIES INCANDA080731_001
7ANDA080776CORTISONE ACETATEHIKMA INTERNATIONAL PHARMACEUTICALS LLCANDA080776_002
8ANDA080836CORTISONE ACETATETrueELKINS SINN DIV AH ROBINS CO INCANDA080836_001
9ANDA083471CORTISONE ACETATETrueBARR LABORATORIES INCANDA083471_001
10ANDA083536CORTISONE ACETATETrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USAANDA083536_001
11ANDA084246CORTISONE ACETATETrueEVERYLIFEANDA084246_001
12ANDA085736CORTISONE ACETATETrueHEATHER DRUG CO INCANDA085736_001
13ANDA085884CORTISONE ACETATETrueWATSON LABORATORIES INCANDA085884_001
14NDA007750CORTONETrueMERCK AND CO INCNDA007750_003
15NDA008126CORTISONE ACETATETruePHARMACIA AND UPJOHN CONDA008126_001, NDA008126_002, NDA008126_003, NDA008126_004
16NDA008284CORTISONE ACETATETruePANRAY CORP SUB ORMONT DRUG AND CHEMICAL CO INCNDA008284_001, NDA008284_002
17NDA009458CORTISONE ACETATETrueIMPAX LABORATORIES INCNDA009458_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapplication
1ANDA080333_001discontinuedCORTISONE ACETATE (25MG)ORALTABLETFalseCORTISONE ACETATE
2ANDA080341_001discontinuedCORTISONE ACETATE (25MG)ORALTABLETFalseCORTISONE ACETATE
3ANDA080493_001discontinuedCORTISONE ACETATE (25MG)ORALTABLETFalseCORTISONE ACETATE
4ANDA080630_001discontinuedCORTISONE ACETATE (25MG)ORALTABLETFalseCORTISONE ACETATE
5ANDA080694_001discontinuedCORTISONE ACETATE (25MG)ORALTABLETFalseCORTISONE ACETATE
6ANDA080731_001discontinuedCORTISONE ACETATE (25MG)ORALTABLETFalseCORTISONE ACETATE
7ANDA080776_002RXCORTISONE ACETATE (25MG)ORALTABLETTrueCORTISONE ACETATE
8ANDA080836_001discontinuedCORTISONE ACETATE (25MG)ORALTABLETFalseCORTISONE ACETATE
9ANDA083471_001discontinuedCORTISONE ACETATE (25MG)ORALTABLETFalseCORTISONE ACETATE
10ANDA083536_001discontinuedCORTISONE ACETATE (25MG)ORALTABLETFalseCORTISONE ACETATE
11ANDA084246_001discontinuedCORTISONE ACETATE (25MG)ORALTABLETFalseCORTISONE ACETATE
12ANDA085736_001discontinuedCORTISONE ACETATE (25MG)ORALTABLETFalseCORTISONE ACETATE
13ANDA085884_001discontinuedCORTISONE ACETATE (25MG)ORALTABLETFalseCORTISONE ACETATE
14NDA007750_003discontinuedCORTISONE ACETATE (25MG)ORALTABLETFalseCORTONE
15NDA008126_001discontinuedCORTISONE ACETATE (25MG)ORALTABLETFalseCORTISONE ACETATE
16NDA008126_002discontinuedCORTISONE ACETATE (25MG/ML)INJECTIONFalseCORTISONE ACETATE
17NDA008126_003discontinuedCORTISONE ACETATE (5MG)ORALTABLETFalseCORTISONE ACETATE
18NDA008126_004discontinuedCORTISONE ACETATE (10MG)ORALTABLETFalseCORTISONE ACETATE
19NDA008284_001discontinuedCORTISONE ACETATE (25MG)ORALTABLETFalseCORTISONE ACETATE
20NDA008284_002discontinuedCORTISONE ACETATE (5MG)ORALTABLETFalseCORTISONE ACETATE
21NDA009458_001discontinuedCORTISONE ACETATE (25MG)ORALTABLETFalseCORTISONE ACETATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1105133d9-2991-4dd2-8d99-beb81aed8aad (view SPL)CORTISONE ACETATE TABLETS, USPprescriptionHuman PrescriptionGolden State Medical Supply, Inc.REPACK2011-07-011604290015
25d59b43c-f10d-463f-92df-6171d02b7a45 (view SPL)CORTISONE ACETATE TABLETS, USPprescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpMANUFACTURE2010-06-085001431202
385cfed58-e5f1-4170-8d83-60e6bebd3610 (view SPL)Cortisone Acetate Tablets, USPprescriptionHuman PrescriptionWest-Ward Pharmaceutical Corp2013-10-012001439700
4f7548498-142c-4feb-83ed-4c20dcd6108b (view SPL)Cortison Acetate Tablets, USPprescriptionHuman PrescriptionHikma Pharmaceutical2013-09-042591150161

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII